Study identification

PURI

https://redirect.ema.europa.eu/resource/49777

EU PAS number

EUPAS1974

Study ID

49777

Official title and acronym

Pharmacovigilance In Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents And/Or Methotrexate. A Pediatric Rheumatology International Trials Organisation (PRINTO)/Pediatric Rheumatology European Society (PRES) Registry (Pharmachild JIA registry)

DARWIN EU® study

No

Study countries

Albania
Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Chile
China
Colombia
Costa Rica
Croatia
Denmark
Egypt
El Salvador
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
India
Iraq
Israel
Italy
Latvia
Libyan Arab Jamahiriya
Lithuania
Mexico
Montenegro
Netherlands
New Zealand
Norway
Oman
Paraguay
Peru
Poland
Portugal
Romania
Russian Federation
Saudi Arabia
Serbia
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Türkiye
United Arab Emirates
United Kingdom
Venezuela, Bolivarian Republic of

Study description

Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease (PRD) and an important cause of short and long-term disability and quality of life impairment. Although none of the available drugs for JIA has a curative potential, prognosis has greatly improved as a result of substantial progress in disease management. The therapeutic treatment of children with JIA encompasses the use of non-steroidal anti-inflammatory drugs (NSAIDs) and intra-articular steroid injections. In those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX, biologic agents recently have become treatment options. This 3-10 year project will observe children with JIA undergoing treatment with MTX or biologic agents, as the primary disease model and has the following objectives: 1. To create a long-term observational registry of a large population of prevalent and incident cases of JIA treated with MTX with or without concurrent biologic agents. 2. Use the accumulating data in the registry to conduct (i) a pharmacovigilance/safety study (primary endpoint) and (ii) estimate effectiveness (frequency and magnitude of response, inhibition or slowing of joint erosions and other radiological evidence of disease progression), and (iii) estimate adherence to the various treatment regimens. Data from the registry will be used to compare safety and effectiveness profiles amongst the patient cohorts. 3. To identify clinical and laboratory predictors of safety, response to therapy, including remission The rationale underpinning this collaborative project is to combine the efforts of paediatric rheumatologists belonging to the PRINTO/PRES network in order to guarantee a critical mass of patients’ data and to provide systematically obtained evidence for development of guidelines for health authorities.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Paediatric Rheumatology International Trials Organisation (PRINTO)
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
First published:
06/10/2022
Network
ENCePP partner

Contact details

Nicolino Ruperto

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

EU project number 260353
Study protocol
Initial protocol

Pharmachild_protocol_v3

English (242.64 KB - PDF)View document
Updated protocol

Pharmachild_protocol_v4

English (243.63 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable